Evaluate Effects and Safety of Pre-load Myfortic® in Transplant Patients

Official Title ICMJE

A 12-month, Prospective, Randomized, Dual Center, Open Label Pilot Study to Evaluate the Safety and Efficacy of Myfortic® (Mycophenolic Acid) Loading Regimens in Combination With Thymoglobulin® [Anti-thymocyte Globulin (Rabbit)] or Simulect® (Basiliximab) Induction and Prograf® (Tacrolimus) in Early Corticosteroid Withdrawal

Brief Summary

This study is specifically designed to determine whether the initiation of Myfortic 2 weeks prior to transplantation will enhance the therapeutic efficacy of Simulect induction therapy in low to moderate risk patients. Specifically, the addition of Myfortic pretransplant to Simulect induction will be compared to standard Myfortic therapy with Thymoglobulin induction starting at the time of transplant in kidney transplant recipients.

Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)

Intervention: Drug: mycophenolic acid

Active Comparator: Myfortic standard

Myfortic at time of transplant with Thymoglobulin induction

Intervention: Drug: mycophenolic acid

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Enrollment ICMJE

61

Completion Date

April 2014

Primary Completion Date

April 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Patients capable of understanding the purposes and risks of the study.

Patients who can give written informed consent, and who are willing and able to participate in the full course of the study.

Women of childbearing potential must have a negative serum pregnancy test within the last 48 hours prior to receiving study medication.

Women of childbearing potential must use two reliable forms of contraception simultaneously, unless they are status post bilateral tubal ligation, bilateral oophorectomy, or hysterectomy. Effective contraception must be used before beginning study drug therapy, for the duration of the study and for 6 weeks following completion of the study.

Exclusion Criteria:

Patients who are recipients of a multiple organ transplant or if the patient previously received and organ transplant.

Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication; diabetic patients with previously diagnosed diabetic gastroenteropathy, or patients with active peptic ulcer disease.

Patient is receiving chronic steroid therapy at the time of transplant.

Patients with a history of malignancy within the last five years, except for successfully excised squamous or basal cell carcinoma of the skin.

Patient is pregnant or lactating, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by positive human Chorionic Gonadotropin (hCG) laboratory test.

Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator.

Inability to cooperate or communicate with the investigator.

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects